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Clinical Trials in Japan / NCT06332885
Recruiting Observational

Zephyr Valve Japan Post-Marketing Surveillance

NCT06332885 · tracked via the Priya Life Science Japan tracker
Sponsor
Pulmonx Corporation
Phase
Observational
Started
2024-03-12
Last updated
2026-09-17

Condition(s) studied

EmphysemaCOPDSevere Emphysema

Investigational drug(s) / intervention(s)

Zephyr Endobronchial Valve

Zephyr Endobronchial Valve: Zephyr Valve provides an alternative technique to achieve bronchoscopic lung volume reduction (BLVR) using a minimally invasive approach. Zephyr Valve is a tiny unidirectional valve. During BLVR, multiple valves are placed to occlude a hyperinflated lobe of the lungs, allowing air to escape while blocking airflow into the treated lobe. This is intended to result in a reduction in lung volume and hyperinflation in the targeted area. Consequently, the remaining lobes can expand more fully, the overall lung works more efficiently, with resultant improvement in overall lung function in patients with hyperinflation associated with severe emphysema.

Study summary

This is a multicenter, prospective, observational surveillance enrolling 140 consecutive patients with severe emphysema who are candidates for bronchoscopic lung volume reduction using Zephyr Endobronchial Valve at up to 20 centers across Japan and followed for 12 months.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patient is deemed eligible for BLVR using Zephyr Valve, as determined by their treating physician in accordance with Japanese guidelines and approved instruction for use. These include: * Recent respiratory rehabilitation completed within the last 6 months * Not actively smoking (for at least 4 months) * TLC ≥ 100% * RV ≥ 175% * FEV1 15-45% post-bronchodilator * 6MWD 100-500 m * mMRC score ≥ 2 * No coagulation disorder * No evidence of active respiratory infection 2. Patient has little to no collateral ventilation (CV-) between the target and ipsilateral lobe as confirmed by Chartis prior to undergoing BLVR. 3. Patient is willing and able to provide informed consent to allow data collection. Exclusion Criteria: None

Primary outcome measure(s)

  • Incidence rate of pneumothorax at 45-days post-Zephyr Valve index procedure. — 45-days post-Zephyr Valve index procedure
    The percentage of study subjects who experience pneumothorax within 45-days post-Zephyr Valve index procedure.

Trial sites (17)

FacilityCityRegionStatus
Tosei General Hospital Aichi Japan Recruiting
Gifu Prefectural Medical Center Gifu Japan Recruiting
Kanagawa Cardio Chest Center Kanagawa Japan Recruiting
Kanazawa University Hospital Kanazawa Japan Recruiting
St Marianna University Hospital Kawasaki Japan Recruiting
Matsusaka Civic Hospital Mie Japan Recruiting
Nagasaki University Hospital Nagasaki Japan Recruiting
Nagoya Medical Center Nagoya Japan Recruiting
Okayama Medical Center Okayama Japan Recruiting
Kinki Chuo Chest Medical Center Osaka Japan Recruiting
Hokkaido University Hospital Sapporo Japan Recruiting
Tohoku University Hospital Sendai Japan Recruiting
Shiga University Hospital Shiga Japan Recruiting
Tokyo National Hospital Tokyo Japan Recruiting
Fujita Health University Hospital Toyoake Japan Recruiting
Dokkyo University Hospital (Pulmonary Medicine and Clinical Immunology) Utsunomiya Japan Not Yet Recruiting
Dokkyo University Hospital Utsunomiya Japan Recruiting

Other trials for the same condition

Endobronchial Silicone Valve for Patients With Emphysema Recruiting
Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot Study Recruiting
Ventilation-Perfusion Discrepancy Index Versus Conventional Anatomic-Physiologic Assessment for Target Lung Lobe Selection in Endobronchial Valve Placement: A Multicenter, Randomised Controlled Trial Starting soon
Pulmonary Deposition of Ultrasound Rock Salt Aerosol Inhalation Therapy Starting soon
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06332885 on ClinicalTrials.gov ↗ ← All trials in Japan